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Inhibitors, ACE
Inhibitors, ACE is a ACE inhibitor Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 3 development for Hypertension, Heart failure, Post-myocardial infarction left ventricular dysfunction.
ACE inhibitors block the angiotensin-converting enzyme, preventing the conversion of angiotensin I to angiotensin II and thereby reducing vasoconstriction and aldosterone release.
ACE inhibitors block the angiotensin-converting enzyme, preventing the conversion of angiotensin I to angiotensin II and thereby reducing vasoconstriction and aldosterone release. Used for Hypertension, Heart failure, Post-myocardial infarction left ventricular dysfunction.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Inhibitors, ACE |
|---|---|
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Drug class | ACE inhibitor |
| Target | Angiotensin-converting enzyme (ACE) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
By inhibiting ACE, these drugs decrease angiotensin II production, a potent vasoconstrictor and aldosterone stimulator. This leads to vasodilation, reduced blood pressure, decreased sodium and water retention, and improved cardiac function. ACE inhibitors are widely used to manage hypertension and heart failure by modulating the renin-angiotensin-aldosterone system.
Approved indications
- Hypertension
- Heart failure
- Post-myocardial infarction left ventricular dysfunction
- Diabetic nephropathy
Common side effects
- Cough
- Dizziness
- Hyperkalemia
- Angioedema
- Hypotension
Key clinical trials
- Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES) (NA)
- A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease (PHASE1, PHASE2)
- Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection
- Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN (PHASE2)
- Venous Congestion And Cognitive Dysfunction After Cardiac Surgery
- A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria (PHASE3)
- Chaigui Longmu Ejiao Paste for Ischemic Heart Disease (PHASE2)
- The GUARDIAN Pilot Trial (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Inhibitors, ACE CI brief — competitive landscape report
- Inhibitors, ACE updates RSS · CI watch RSS
- National Heart, Lung, and Blood Institute (NHLBI) portfolio CI
Frequently asked questions about Inhibitors, ACE
What is Inhibitors, ACE?
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What are the side effects of Inhibitors, ACE?
What does Inhibitors, ACE target?
Related
- Drug class: All ACE inhibitor drugs
- Target: All drugs targeting Angiotensin-converting enzyme (ACE)
- Manufacturer: National Heart, Lung, and Blood Institute (NHLBI) — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertension
- Indication: Drugs for Heart failure
- Indication: Drugs for Post-myocardial infarction left ventricular dysfunction
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing